FDA Approves Merck & Co’s Keytruda for High-Risk, Non-Muscle Invasive Bladder Cancer

January 10, 2020

The approval was based on successful data from a years-long trial that assessed patient’s tumor status every 12 or 24 weeks for up to 24 months.

On Jan. 8, 2020, Merck & Co. announced FDA approved Keytruda (pembrolizumab), an anti-programmed cell death-1 (PD-1) therapy, for the treatment of Bacillus Calmette-Guerin (BCG), a high-risk, non-muscle invasive bladder cancer with carcinoma in situ (CIS) in patients with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. Keytruda is Merck’s top-selling drug, with nearly $7.2 billion in 2018 sales.

The therapy works to increase the ability of the body’s immune system to help detect and fight tumor cells by blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, to activate the lymphocytes that affect tumor cells and healthy cells, according to a company press release. The approval was based on successful data from a years-long trial that assessed patient’s tumor status every 12 or 24 weeks for up to 24 months.

“High-risk, non-muscle invasive bladder cancer is a serious disease, characterized by frequent recurrences and progression,” said Arjun V. Balar, MD, associate professor of Medicine and director of Genitourinary Medical Oncology at NYU Langone Health’s Perlmutter Cancer Center, in the press release. “Historically, patients with high-risk, non-muscle invasive bladder cancer with CIS whose cancer is unresponsive to BCG treatment had limited non-surgical treatment options. As a physician who specializes in the management of bladder cancer, it is encouraging to now have a new treatment option for these patients.”

“Today’s approval of Keytruda reinforces our company’s commitment to expanding existing treatment options for certain patients with high-risk, non-muscle invasive bladder cancer,” added Dr. Scot Ebbinghaus, vice-president, clinical research, Merck Research Laboratories, in the press release. “As the first anti-PD-1 therapy approved in this setting, Keytruda will be a new clinical option for a patient population that previously had limited FDA-approved therapies available.”

Keytruda is also approved by FDA to treat melanoma, non-small cell lung cancer, and head and neck cancer.

Source: Merck